CN115500996A - Positioning zone for endovascular procedures - Google Patents

Abstract

Translated fromChinese

描述了构建用于血管内手术的定位区的系统和方法。该手术是“混合的”，因为它涉及直接进入(例如，胸骨切开术或部分胸骨切开术)到用于安装定位区的部位，以及一旦安装了定位区，在血管内安装TAVR或TEVAR装置(例如，支架移植物)。通过将定位带包裹血管的一部分安装定位区。定位带可以被选择以固定在一定直径上，从而抑制血管的任何膨胀，并且还支撑稍后安装的TAVR或TEVAR装置。然后将TAVR或TEVAR装置在血管内递送至血管并在其中展开。该装置扩张，直到它接触到由定位带从外部支撑的血管，从而从外部约束和支撑该装置。

Systems and methods for constructing localization regions for endovascular procedures are described. The procedure is "hybrid" because it involves direct access (e.g., sternotomy or partial sternotomy) to the site used to install the targeting zone, and once the targeting zone is installed, endovascular placement of TAVR or TEVAR Devices (eg, stent grafts). The positioning zone is installed by wrapping the positioning tape around a portion of the vessel. The positioning strap can be selected to be fixed at a diameter that inhibits any expansion of the vessel and also supports a later installed TAVR or TEVAR device. The TAVR or TEVAR device is then delivered intravascularly to and deployed within the blood vessel. The device expands until it contacts the blood vessel externally supported by the positioning band, thereby constraining and supporting the device externally.

Description

Translated fromChinese

用于血管内手术的定位区Positioning zone for endovascular procedures

技术领域technical field

本公开涉及在诸如升主动脉的血管中构建用于血管内手术的定位(landing)区。The present disclosure relates to creating landing regions for endovascular procedures in vessels such as the ascending aorta.

背景技术Background technique

血管内手术的使用已被确立为一种微创技术，可在患者的脉管系统中提供多种临床治疗方法。支架移植物是由管状外科移植物覆盖物和扩张或自扩张框架制成的可植入装置。将支架移植物放置在血管内以桥接例如动脉瘤、解剖的或其他患病或撕裂的血管段，从而从患病的血管段中排除血流的血流动力学压力。The use of endovascular surgery has been established as a minimally invasive technique to deliver a variety of clinical treatments within a patient's vasculature. A stent-graft is an implantable device made of a tubular surgical graft covering and an expanding or self-expanding frame. A stent-graft is placed within a blood vessel to bridge, eg, aneurysmal, dissected or other diseased or torn vessel segments, thereby removing the hemodynamic stress of blood flow from the diseased vessel segment.

取决于所涉及的主动脉的区域，动脉瘤可延伸至具有血管分支或主动脉段的区域，较小的“分支”动脉从该区域延伸。例如，胸主动脉瘤可包括存在于升胸主动脉、主动脉弓和/或从中散发的分支动脉例如左锁骨下动脉、左颈总动脉或头臂动脉中的动脉瘤。在某些情况下，有分支的支架移植物可用于治疗此类动脉瘤。例如，可以在主血管(例如主动脉弓)中部署有分支的支架移植物，其中联接器(coupling)从其延伸并朝向或进入分支动脉(例如，左锁骨下动脉)，并且可以将补充的辅助支架移植物部署在分支动脉中并连接到联接器。Depending on the area of the aorta involved, the aneurysm can extend into areas with vessel branches or segments of the aorta from which smaller "branch" arteries extend. For example, thoracic aortic aneurysms may include aneurysms present in the ascending thoracic aorta, the aortic arch, and/or branch arteries emanating therefrom, such as the left subclavian, left common carotid, or brachiocephalic arteries. In some cases, branched stent-grafts may be used to treat such aneurysms. For example, a branched stent-graft can be deployed in the main vessel (e.g., aortic arch) with couplings extending therefrom and towards or into a branch artery (e.g., left subclavian artery), and a supplementary auxiliary stent-graft can be placed A graft is deployed in a branch artery and connected to a coupler.

发明内容Contents of the invention

根据一个实施例，一种为患者血管中的支架移植物提供支撑的方法包括：围绕血管的一部分的外部包裹定位带，然后固定定位带以使其保持选定的直径，然后在血管内将呈径向收缩构造的支架移植物递送到血管中，然后移除外护套以允许支架移植物扩张至径向扩张构造，直到支架移植物接触被定位带包裹的血管部分，使得定位带从血管的外部支撑支架移植物。According to one embodiment, a method of providing support for a stent graft in a patient's blood vessel includes wrapping a positioning band around the exterior of a portion of the vessel, securing the positioning band so that it maintains a selected diameter, and then positioning the positioning band within the vessel. The stent-graft in the radially contracted configuration is delivered into the vessel, and the outer sheath is then removed to allow the stent-graft to expand to the radially-expanded configuration until the stent-graft contacts the portion of the vessel wrapped by the positioning band such that the positioning band disengages from the vessel's External support stent graft.

根据一个实施例，一种将支架移植物固定在患者血管内的方法包括将定位带包裹在血管的一部分的外部，固定所述定位带以使其保持选定的直径，在血管内经由内锚引导器递送支架移植物进入被定位带包裹的血管的一部分，将内锚在血管内递送通过血管并进入由于定位带而被抑制扩张血管的支架移植物，并且使缝合线向外挤压穿过支架移植物、血管壁和定位带。According to one embodiment, a method of securing a stent-graft within a patient's blood vessel includes wrapping a positioning band around the exterior of a portion of the vessel, securing the positioning band so that it maintains a selected diameter, within the vessel via an inner anchor The introducer delivers the stent-graft into a portion of the vessel wrapped by the positioning band, delivers the inner anchor intravascularly through the vessel and into the stent-graft that is inhibited from dilating the vessel due to the positioning band, and squeezes the suture outward through Stent grafts, vessel walls and positioning tapes.

根据一个实施例，一种用于构建用于血管内手术的定位区的系统包括定位带，该定位带被配置为包裹患者的血管的一部分，其中定位带上具有测量标记，该测量标记被配置为帮助外科技术人员选择用于支撑在血管的所述部分周围的固定直径。该系统还包括支架移植物，该支架移植物被配置成在血管内被递送到由定位带包裹的血管的所述部分。该系统还包括内引导器，其配置成在血管内被递送到由定位带固定的血管的所述部分，其中内引导器携带缝合线并且配置成当由外科技术人员操作时，将缝合线挤压穿过支架移植物、穿过血管壁并穿过定位带，以将支架移植物固定在定位带上。According to one embodiment, a system for constructing a positioning zone for endovascular procedures includes a positioning band configured to wrap around a portion of a patient's blood vessel, wherein the positioning band has measurement markings configured to To assist the surgical technician in selecting a fixed diameter for support around said portion of the vessel. The system also includes a stent-graft configured to be delivered intravascularly to the portion of the vessel wrapped by the positioning band. The system also includes an inner guide configured to be delivered intravascularly to the portion of the blood vessel secured by the positioning band, wherein the inner guide carries a suture and is configured to squeeze the suture when operated by the surgical technician. Press through the stent-graft, through the vessel wall, and through the positioning tape to secure the stent-graft to the positioning tape.

附图说明Description of drawings

图1是根据一个实施例的具有位于窦管交界处(STJ)附近的动脉瘤的升主动脉的示意图。1 is a schematic illustration of the ascending aorta with an aneurysm located near the sinotubular junction (STJ), according to one embodiment.

图2-9图示了构建用于支撑经导管主动脉瓣置换(TAVR)装置或胸腔血管内主动脉修复(TEVAR)装置(例如支架移植物)的定位区的方法的各个步骤，其中：2-9 illustrate various steps in a method of constructing a positioning zone for supporting a transcatheter aortic valve replacement (TAVR) device or thoracic endovascular aortic repair (TEVAR) device, such as a stent-graft, wherein:

图2显示了围绕STJ附近血管包裹的定位带；Figure 2 shows the localization band wrapped around the vessel near the STJ;

图3显示了定位带被系紧到所需的直径并被夹紧；Figure 3 shows the positioning strap being tightened to the desired diameter and clamped;

图4显示了用紧固件将定位带固定成其直径；Figure 4 shows the fastening of the positioning strap to its diameter with fasteners;

图5显示了将支架移植物递送到血管中的支架移植物递送系统；Figure 5 shows a stent graft delivery system for delivering a stent graft into a blood vessel;

图6显示了径向扩张构型的支架移植物；Figure 6 shows a stent graft in a radially expanded configuration;

图7显示了支架移植物通过内锚从血管内部附接到定位带；Figure 7 shows the attachment of the stent-graft to the positioning band from the inside of the vessel via the inner anchor;

图8A显示了被递送到血管内所需位置的内锚的放大视图，而图8B显示了携带缝合线的针头，该缝合线刺穿血管壁、支架移植物和定位带，以允许从血管外部系住缝合线；和Figure 8A shows a magnified view of the inner anchor being delivered to the desired location within the vessel, while Figure 8B shows the needle carrying the suture that pierces the vessel wall, stent-graft, and positioning tape to allow access from outside the vessel. tie the sutures; and

图9显示了支架移植物和定位带的完整连接。Figure 9 shows the complete attachment of the stent-graft and positioning straps.

图10显示了具有逆行A型主动脉夹层(RTAD)的血管。Figure 10 shows a vessel with retrograde type A aortic dissection (RTAD).

图11显示了图10的血管，其定位带固定在与主要入口撕裂重叠并邻近STJ的位置。Figure 11 shows the vessel of Figure 10 with the positioning band fixed in place overlapping the main entry tear and adjacent to the STJ.

图12显示了一个实施例，其中定位带用于支撑在血管内递送的瓣膜。Figure 12 shows an embodiment where a positioning strap is used to support the valve for intravascular delivery.

图13显示了一个实施例，其中支架移植物被展开并且也由支撑瓣膜的相同定位带支撑。Figure 13 shows an embodiment where the stent-graft is deployed and is also supported by the same positioning bands that support the valve.

具体实施方式detailed description

在此描述本发明的实施例。然而，应当理解，所公开的实施例仅是示例，并且其他实施例可以采取各种和替代形式。这些图不一定按比例绘制；一些特征可能被放大或最小化以显示特定部件的详细信息。因此，本文公开的具体结构和功能细节不应被解释为限制性的，而仅仅是作为教导本领域技术人员以各种方式应用实施例的代表性基础。如本领域普通技术人员将理解的，参照任何一个附图示出和描述的各种特征可以与在一个或多个其他附图中示出的特征结合以产生未明确示出或描述的实施例。所示特征的组合为典型应用提供了代表性实施例。然而，对于特定的应用或实现，可能期望对与本发明的教导一致的特征进行各种组合和修改。Embodiments of the invention are described herein. It should be understood, however, that the disclosed embodiments are examples only, and that other embodiments may take various and alternative forms. The figures are not necessarily to scale; some features may be exaggerated or minimized to show details of particular components. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a representative basis for teaching one skilled in the art to variously employ the embodiments. As will be understood by persons of ordinary skill in the art, various features shown and described with reference to any one figure can be combined with features shown in one or more other figures to create embodiments not explicitly shown or described . Combinations of features shown provide representative embodiments for typical applications. However, various combinations and modifications of the features consistent with the teachings of the invention may be desired for particular applications or implementations.

本文中使用的方向性术语是参照示例性附图中所示的视图和取向做出的。在图中示出并在下面描述了中心轴线。“外部”和“内部”等术语是相对于中心轴线而言的。例如，“外”表面是指此表面背离中心轴线，或者位于另一个“内”表面的外侧。“径向”、“直径”、“周长”等术语也相对于中心轴线而言的。术语“前”、“后”、“上”和“下”表示附图中所参考的方向。Directional terms used herein are made with reference to the views and orientations shown in the exemplary drawings. The central axis is shown in the figures and described below. Terms such as "outer" and "inner" are relative to the central axis. For example, an "outer" surface means that the surface faces away from the central axis, or outside of another "inner" surface. Terms such as "radial", "diameter", and "circumference" are also relative to the central axis. The terms "front", "rear", "upper" and "lower" denote directions to which reference is made in the drawings.

除非另有说明，否则对于递送系统，在以下描述中，关于相对于治疗临床医生的位置或方向使用术语“远侧的”和“近侧的”。“远侧(distal)”和“向远侧(distally)”是远离临床医生或在远离临床医生的方向上的位置，并且“近侧(proximal)”和“向近侧(proximally)”是靠近临床医生或在朝临床医生的方向上的位置。对于支架移植物假体，“近侧”是指通过血液流动路径更靠近心脏的部分，而“远侧”是指通过血液流动路径更远离心脏的支架移植物的部分。Unless otherwise stated, with respect to delivery systems, in the following description the terms "distal" and "proximal" are used with respect to position or orientation relative to the treating clinician. "Distal" and "distally" are locations away from or in a direction away from the clinician, and "proximal" and "proximally" are near The location of the clinician or in the direction of the clinician. With respect to a stent-graft prosthesis, "proximal" refers to the portion of the stent-graft that is closer to the heart by the blood flow path, and "distal" refers to the portion of the stent-graft that is further from the heart by the blood flow path.

以下详细描述本质上仅是示例性的并且不旨在限制本发明或本发明的应用和用途。尽管该描述是在诸如主动脉的血管的治疗的背景下，但是本发明也可以在认为有用的任何其他动脉或身体通道中使用。The following detailed description is merely exemplary in nature and is not intended to limit the invention or the application and uses of the invention. Although this description is in the context of the treatment of blood vessels such as the aorta, the invention may also be used in any other artery or body passage deemed useful.

在升主动脉的血管内手术过程中，主动脉解剖通常不利于密封支架移植物。许多升弓动脉瘤缺乏足以正确密封支架移植物的近侧密封区。图1显示了升主动脉10的实例，其具有位于窦管交界处(STJ)14附近的动脉瘤12。为了上下文，主动脉10显示为具有头臂动脉16、左颈总动脉18和左锁骨下动脉20，并且STJ 14位于右冠状动脉22和左冠状动脉24附近和远侧。在某些疾病状态下，例如逆行A型主动脉夹层(RTAD)，其主要入口撕裂或疾病发生在STJ 14附近(例如，在2厘米内)，STJ 14处沿主动脉10的组织不足以密封展开的支架移植物。简而言之，动脉瘤有时可能位于产生少量健康组织以正确安装支架移植物的位置。在STJ 14附近植入支架时，人们担心来自支架移植物的持续向外径向力会影响瓣膜的结构，可能导致主动脉不足。不利的解剖结构限制了可以使用纯血管内手术治疗的潜在患者的百分比。在该区域不存在钙化环的情况下，目前提出的瓣膜可能无法很好地密封。当前提出的瓣膜也可能易于迁移。如本文在一个或多个实施例中所公开的定位区或带可以解决当前提出的瓣膜的一个或多个缺点。一个或多个实施例中的定位区或带可以充分固定支架移植物并且可以防止疾病进展。Aortic anatomy is often not conducive to sealing the stent-graft during endovascular procedures in the ascending aorta. Many ascending arch aneurysms lack a proximal seal zone sufficient to properly seal the stent-graft. FIG. 1 shows an example of anascending aorta 10 with ananeurysm 12 located near a sinotubular junction (STJ) 14 . For context, theaorta 10 is shown with thebrachiocephalic artery 16 , the leftcommon carotid artery 18 , and the leftsubclavian artery 20 , and theSTJ 14 is located near and distal to the right 22 and left 24 coronary arteries. In certain disease states, such as retrograde type A aortic dissection (RTAD), where the primary inlet is torn or the disease occurs near (eg, within 2 cm) theSTJ 14, there is insufficient tissue along theaorta 10 at the STJ 14 Seal the deployed stent-graft. In short, an aneurysm can sometimes be in a location that produces a small amount of healthy tissue to properly fit the stent-graft. When stenting nearSTJ 14, there is concern that the sustained outward radial force from the stent-graft could affect the structure of the valve, possibly leading to aortic insufficiency. Unfavorable anatomy limits the percentage of potential patients who can be treated with purely endovascular surgery. In the absence of a calcified ring in this area, the currently proposed valve may not seal well. The currently proposed valve may also be prone to migration. A positioning zone or band as disclosed herein in one or more embodiments may address one or more disadvantages of currently proposed valves. The positioning zones or bands of one or more embodiments can sufficiently immobilize the stent-graft and prevent disease progression.

因此，根据本文所述的各种实施例，公开了用于支撑支架移植物的定位区或定位带。还公开了用于手术植入和安装设计的定位区的混合手术/血管内方法，以为经导管主动脉瓣置换(TAVR)和胸腔血管内主动脉修复(TEVAR)装置(例如支架移植物等)提供合适的密封和固定。为了治疗缺乏足够自然定位区的升主动脉病变，可以安装定位带来提供一个定位区。一个或多个实施例中的方法是“混合的”，因为它涉及直接进入(例如，胸骨切开术或部分胸骨切开术)到用于安装定位带的部位，以及一旦安装了定位带，在血管内安装TAVR或TEVAR装置(例如，支架移植物)。一个或多个实施例中的混合方法可具有避免将患者置于循环停止或有时需要用于开放式手术修复的一个或多个旁路泵上的优点。循环停止和旁路泵程序通常与显著的发病率和死亡率相关。患有严重合并症的老年患者可能过于虚弱，无法进行开放式修复。其他非手术患者可能缺乏用于血管内修复的良好解剖结构。一个或多个实施例中的混合方法可以为一些老年患者和/或非手术患者提供替代方案。Thus, according to various embodiments described herein, a positioning zone or band for supporting a stent-graft is disclosed. Also disclosed is a hybrid surgical/endovascular approach for surgical implantation and installation of designed positioning zones for transcatheter aortic valve replacement (TAVR) and thoracic endovascular aortic repair (TEVAR) devices (e.g., stent grafts, etc.) Provide proper sealing and securing. For the treatment of ascending aortic lesions that lack an adequate natural positioning zone, positioning straps can be installed to provide a positioning zone. The method in one or more embodiments is "hybrid" in that it involves direct access (e.g., sternotomy or partial sternotomy) to the site for the positioning strap, and once the positioning strap is installed, A TAVR or TEVAR device (eg, a stent-graft) is installed within the vessel. The hybrid approach in one or more embodiments may have the advantage of avoiding placing the patient on one or more bypass pumps that are circulatory stopped or sometimes required for open surgical repair. Circulation stop and bypass pump procedures are often associated with significant morbidity and mortality. Elderly patients with severe comorbidities may be too frail for open repair. Other nonsurgical patients may lack good anatomy for endovascular repair. A hybrid approach in one or more embodiments may provide an alternative for some elderly patients and/or non-surgical patients.

图2-9示出了根据实施例的安装定位带以提供定位区以固定TAVR或TEVAR装置的顺序操作。图2图示了正在安装的这种定位带30的示例实施例。一旦主动脉10被自由解剖，定位带30可以在主动脉10下方进给并围绕主动脉10周向包裹以形成用于内移植物的稳定定位区。定位带30可以由手术毡、聚对苯二甲酸乙二醇酯(PET)、膨胀聚四氟乙烯(ePTFE)、聚氨酯(PU)或其他合适的材料制成。在其他实施例中，定位带30可以由组织片(例如，尸体)、细胞基质、胶原蛋白制成，和/或可以是3-D打印的。定位带30可以由偏向弯曲构造的热固性形状记忆聚合物形状构造以简化包裹过程。定位带30的材料可以是机织或针织的实心材料，或者可以是具有开口的网状物。定位带30的材料可以由弹性材料构成，以提供对设计的定位区的一定程度的顺应性并适应血流的脉搏波。2-9 illustrate sequential operations for installing a positioning strap to provide a positioning zone to secure a TAVR or TEVAR device, according to an embodiment. FIG. 2 illustrates an example embodiment of such apositioning strap 30 being installed. Once theaorta 10 is free to dissect, thepositioning band 30 can be advanced under theaorta 10 and wrapped circumferentially around theaorta 10 to form a stable positioning zone for the endograft. Thepositioning tape 30 may be made of surgical felt, polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), polyurethane (PU), or other suitable materials. In other embodiments, positioningstrip 30 may be made from a tissue sheet (eg, cadaver), cell matrix, collagen, and/or may be 3-D printed. Positioningband 30 may be constructed from a thermoset shape memory polymer shape biased toward a curved configuration to simplify the wrapping process. The material of thepositioning strap 30 may be a solid material that is woven or knitted, or may be a mesh with openings. The material of thepositioning band 30 may be constructed of an elastic material to provide a degree of compliance to the designed positioning zone and to accommodate the pulse wave of the blood flow.

定位带30可以具有长度和宽度(例如，从好像定位带30被拉伸并平放的角度来看)。定位带的宽度可以变化，但在实施例中，宽度应该足够宽，以便为以后安装的血管内装置提供合适的定位区。可以将带30的形状设置成期望的构造，以防止带30和主动脉10或其他解剖特征之间的突然顺应性失配。例如，对于上升的动脉瘤，锥部可以是锥形的，较大的开口朝上，以通过产生逐渐过渡来容纳扩张的上升主动脉。在STJ扩张的情况下，圆锥的较大开口可能朝下，以防止与STJ的界面突然不匹配。如果需要，可以安装多个定位带30，或者升主动脉10的整个长度可以包裹在定位带30中。Thepositioning strap 30 may have a length and a width (eg, from a perspective as if thepositioning strap 30 was stretched and lay flat). The width of the positioning band can vary, but in embodiments the width should be wide enough to provide a suitable positioning area for a later installed intravascular device.Band 30 may be shaped into a desired configuration to prevent sudden compliance mismatches betweenband 30 andaorta 10 or other anatomical features. For example, for an ascending aneurysm, the taper may be tapered with the larger opening facing upwards to accommodate the dilated ascending aorta by creating a gradual transition. In the case of STJ dilation, the larger opening of the cone may face downward to prevent a sudden mismatch at the interface with the STJ.Multiple positioning bands 30 may be installed if desired, or the entire length of the ascendingaorta 10 may be wrapped inpositioning bands 30 .

如图2中的实施例所示，定位带30可以包括测量标记32。测量标记32可以包括多条间隔开的线34，每条线34代表一个长度单位。这允许外科技术人员知道有多少定位带30包裹在主动脉10周围，例如，定位带30具有多少直径。在一个实例中，定位带30的内表面具有标记36，该标记与带材料的外表面上以毫米渐变间隔开的线34对齐，以允许医生将带束紧至规定直径。可以将不透射线标记添加到近侧和远侧材料边缘，以便在透视期间可以看到带的位置。As shown in the embodiment of FIG. 2 , thepositioning strip 30 may include measurement marks 32 .Measurement mark 32 may include a plurality of spaced apart lines 34, eachline 34 representing a unit of length. This allows the surgical technologist to know howmuch positioning band 30 is wrapped aroundaorta 10, eg, whatdiameter positioning band 30 has. In one example, the inner surface of thepositioning band 30 hasmarkings 36 that align with millimeter-spacedlines 34 on the outer surface of the band material to allow the physician to tighten the band to a prescribed diameter. Radiopaque markers can be added to the proximal and distal material edges so that the position of the bands can be seen during fluoroscopy.

图3示出了图2之后的步骤，在该步骤中，使用测量标记32将定位带30系紧至期望的直径，并夹紧(例如，使用止血器38)。也可以使用夹紧的替代方案，例如缝合线、钉或其他机构，以将定位带30保持在期望的直径，直到它可以被固定。在线36与测量标记32之一重叠的位置进行系紧。如该图所示，带被放置并系紧在与STJ 14刚好远侧或略微重叠的位置。FIG. 3 shows a step following FIG. 2 in which thepositioning band 30 is tightened to the desired diameter using themeasurement marker 32 and clamped (eg, using a hemostat 38 ). Alternatives to clamping, such as sutures, staples, or other mechanisms, may also be used to hold thepositioning band 30 at the desired diameter until it can be secured. The tie is made where theline 36 overlaps one of the measurement marks 32 . As shown in this figure, the strap is placed and fastened just distal to or slightly overlapping theSTJ 14 .

图4显示了固定定位带30的下一步。在所示实施例中，包裹主动脉10的定位带30的两个半部分通过紧固件40彼此固定。紧固件40可以是缝合线、钉、夹子或其他闭合机构。如果在系紧步骤期间使用了夹紧的替代方案，那么这些也可以是闭合机构，或者它们可以被移除并且可以使用新的/不同的闭合机构来固定定位带。或者，定位带30可以使用类似钩环(例如，VELCRO)的材料或自棘轮机构来固定。一旦固定，就可以将定位带30的松散剩余部分修剪至所需的长度。FIG. 4 shows the next step in securing thepositioning strap 30 . In the illustrated embodiment, the two halves of positioningband 30 that wraps aroundaorta 10 are secured to each other byfasteners 40 .Fasteners 40 may be sutures, staples, clips, or other closure mechanisms. If an alternative to clamping was used during the tightening step, these could also be the closure mechanism, or they could be removed and a new/different closure mechanism could be used to secure the positioning strap. Alternatively, thepositioning strap 30 may be secured using a hook and loop (eg, VELCRO) like material or self-ratcheting mechanism. Once secured, the loose remainder ofpositioning strap 30 can be trimmed to the desired length.

图5显示了下一步骤，其中支架移植物42递送通过升主动脉10。支架移植物42只是TEVAR装置或TAVR装置的一个实例，其可以被递送以固定到定位带30。在该步骤期间，可以将导丝44经血管内馈送到升主动脉10中的期望位置。支架移植物输送系统例如由MEDTRONIC出售的已知VALIANT NAVION或VALIANT CAPTIVIA系统可以沿着导丝跟踪支架移植物42，其中外护套或内腔46在其中包含呈径向收缩构造的支架移植物42。然后，当就位时，递送系统可以使外腔46或护套缩回，从而使支架移植物42径向向外扩张。然而，定位带30和相关方法可以与任何TEVAR或TAVR装置和递送系统一起使用。FIG. 5 shows the next step in which astent graft 42 is delivered through the ascendingaorta 10 .Stent graft 42 is just one example of a TEVAR device or TAVR device that may be delivered secured to positioningstrap 30 . During this step, a guidewire 44 may be endovascularly fed to the desired location in the ascendingaorta 10 . A stent-graft delivery system such as the known VALIANT NAVION or VALIANT CAPTIVIA systems sold by MEDTRONIC can track the stent-graft 42 along a guide wire with an outer sheath orlumen 46 containing the stent-graft 42 therein in a radially contracted configuration . Then, when in place, the delivery system may retract theouter lumen 46 or sheath, thereby expanding thestent graft 42 radially outward. However, thepositioning tape 30 and related methods may be used with any TEVAR or TAVR device and delivery system.

图6显示了处于完全展开或径向扩张构型的支架移植物42，其中外腔和导丝缩回和移除。现在展开的支架移植物42可以实现与由定位带30在升主动脉10的近侧部分50处产生的定位区的密封。定位带30提供主动脉10的支撑并防止支架移植物42的径向力扩张STJ14。配备有定位带30的主动脉10的近侧部分50因此可以被称为近侧定位区。Figure 6 shows thestent graft 42 in a fully deployed or radially expanded configuration with the outer lumen and guidewire retracted and removed. The now-deployed stent-graft 42 can achieve a seal against the positioning zone created by thepositioning band 30 at theproximal portion 50 of the ascendingaorta 10 . Positioningband 30 provides support foraorta 10 and prevents radial forces ofstent graft 42 from expandingSTJ 14 . Theproximal portion 50 of theaorta 10 equipped with thepositioning band 30 may thus be referred to as the proximal positioning zone.

图6还示出了升主动脉10的远侧部分52。定位带可以围绕远侧部分52放置以形成远侧定位区。根据所治疗的疾病和动脉瘤的位置，可以通过使用一个或多个定位带30来创建远侧定位区或近侧定位区之一或两者。或者，可以提供单个大定位带，其围绕降主动脉10从远侧部分52包裹到近侧部分50。单个定位带可以具有从近侧部分延伸到远侧部分的宽度，或者它可以具有较小的宽度但较长的长度，使得它可以螺旋包裹以覆盖整个高度。FIG. 6 also shows the distal portion 52 of the ascendingaorta 10 . A positioning band may be placed around distal portion 52 to form a distal positioning zone. Depending on the disease being treated and the location of the aneurysm, one or both of the distal or proximal positioning zones may be created through the use of one ormore positioning bands 30 . Alternatively, a single large positioning band may be provided that wraps around the descendingaorta 10 from the distal portion 52 to theproximal portion 50 . A single positioning band may have a width extending from the proximal portion to the distal portion, or it may have a smaller width but a longer length such that it can be helically wrapped to cover the entire height.

如图6中可见，支架移植物42的近端54可向近侧延伸超过定位带30。这确保了在支架移植物42和定位带30之间提供完全密封。然而，在其他实施例中，近端54可以落到定位带30内。As can be seen in FIG. 6 ,proximal end 54 ofstent graft 42 may extend proximally beyond positioningband 30 . This ensures that a complete seal is provided between thestent graft 42 and thepositioning band 30 . In other embodiments, however, theproximal end 54 may drop within thepositioning band 30 .

由于混合程序提供的直接通路，支架移植物42可以永久地固定到定位带30。支架移植物42可以任何合适的方式固定到定位带30。在一个实施例中，支架移植物42可以通过例如使用针驱动器和弯曲缝合针从外部缝合而固定到定位带30。缝合被配置为降低装置对血流迁移力的敏感性，从而使装置更能抵抗由于主动脉中的心脏和/或呼吸引起的运动而引起的位移。定位带30的材料为主动脉提供支撑并且防止主动脉10由于持续的疾病进展而持续扩张。支架移植物42对着落带30的压力有助于防止形成I型内漏。而且，由于混合通路，任何确实发生的泄漏都可以被直接扎住。Stent-graft 42 may be permanently affixed to positioningstrap 30 due to the direct access provided by the hybrid procedure.Stent graft 42 may be secured to positioningstrap 30 in any suitable manner. In one embodiment,stent graft 42 may be secured to positioningband 30 by external suturing, for example, using a needle driver and a curved suture needle. The sutures are configured to reduce the sensitivity of the device to the migratory forces of blood flow, thereby making the device more resistant to displacement due to cardiac and/or respiratory induced motion in the aorta. The material of thepositioning band 30 provides support to the aorta and prevents continued dilation of theaorta 10 due to ongoing disease progression. The pressure of thestent graft 42 against thelanding zone 30 helps prevent the formation of a Type I endoleak. Also, any leaks that do occur can be directly tied due to the mixing pathway.

或者，如图7所示，支架移植物42可以从主动脉10的内部附接到定位带30。例如，这可以通过内锚56在血管内完成。内锚56可以被部署以瞄准定位带30的较厚部分，或者可以添加额外的材料以形成坚固的附接。可以使用合适的系统，例如HELI-FX ENDOANCHOR系统(可从MEDTRONIC获得)来递送内锚。这可以包括将内锚引导器58，例如HELI-FX引导器在血管内递送通过主动脉10、通过支架移植物42并且到支架移植物42内部的与定位带30对齐的位置。参考图8A和8B示出并描述了经由内锚56锚固支架移植物42的附加描述。内锚56可以是缝合线，但在其他实施例中，内锚56是钉、锚、形状记忆锚或其他紧固件。Alternatively, as shown in FIG. 7 ,stent graft 42 may be attached to positioningband 30 frominside aorta 10 . This can be done endovascularly viainner anchor 56, for example. Inner anchors 56 may be deployed to target thicker portions ofpositioning strap 30, or additional material may be added to form a strong attachment. The internal anchor can be delivered using a suitable system, such as the HELI-FX ENDOANCHOR system (available from MEDTRONIC). This may include intravascular delivery of aninner anchor guide 58 , such as a HELI-FX guide, through theaorta 10 , through the stent-graft 42 and to a location inside the stent-graft 42 in alignment with thepositioning band 30 . An additional description of anchoring stent-graft 42 viainner anchor 56 is shown and described with reference to FIGS. 8A and 8B .Inner anchor 56 may be a suture, but in other embodiments,inner anchor 56 is a staple, anchor, shape memory anchor, or other fastener.

将支架移植物42锚定到定位带30是在升主动脉10的近侧部分50中进行的，但是如果定位带放置在那里，类似的技术可以用于升主动脉10的远侧部分52。Anchoring of the stent-graft 42 to thepositioning band 30 is performed in theproximal portion 50 of the ascendingaorta 10, but a similar technique can be used for the distal portion 52 of the ascendingaorta 10 if the positioning band is placed there.

参考图8A，内锚引导器58的端部被显示为接合主动脉10的部分(例如，血管壁59)，如图7所示，该部分被定位带30包裹。一旦内锚引导器58被递送到该部位(例如，血管内)，就可以部署内锚56。根据所示实施例，接合在保护套64或内腔内的针保持器62内的一对针60可被追踪通过内锚引导器58并垂直于血管壁59定位。针60的尺寸和它们之间的间距可以由针保持器62的尺寸和间距来确定。然后，推进针保持器62，使得针60被推动穿过支架移植物42的移植物材料，穿过血管壁59，并穿过定位带30。这在图8B中显示，并且所述推进由箭头66显示。然后可以由外科技术人员从血管壁59的外部抓住针60，并且可以拉紧缝合线70直到脱脂棉68接触血管壁59。手术结可用于从血管壁59的外部系住缝合线70。针60连同过量的缝合线可以随后被切割和移除。在打结手术结之前，可以在血管壁59的外部添加额外的脱脂棉。该过程可以根据实施方式重复，以将定位带30充分地固定到主动脉10的血管壁59。Referring to FIG. 8A , the end ofinner anchor guide 58 is shown engaging a portion of aorta 10 (eg, vessel wall 59 ), which is wrapped by positioningband 30 as shown in FIG. 7 . Onceinner anchor introducer 58 has been delivered to the site (eg, within a vessel),inner anchor 56 may be deployed. According to the illustrated embodiment, a pair ofneedles 60 engaged within aprotective sheath 64 orneedle holder 62 within a lumen can be traced through theinner anchor guide 58 and positioned perpendicular to thevessel wall 59 . The size and spacing of theneedles 60 may be determined by the size and spacing of theneedle holders 62 .Needle holder 62 is then advanced such thatneedle 60 is pushed through the graft material ofstent graft 42 , throughvessel wall 59 , and throughpositioning band 30 . This is shown in FIG. 8B and the advancement is shown byarrow 66 . Theneedle 60 can then be grasped by the surgical technician from the outside of thevessel wall 59 and the suture 70 can be pulled taut until thepledget 68 contacts thevessel wall 59 . A surgical knot may be used to tie the suture 70 from the outside of thevessel wall 59 .Needle 60 may then be cut and removed, along with excess suture. Additional pledgets may be added to the exterior of thevessel wall 59 prior to tying the surgical knot. This process may be repeated, depending on the embodiment, to sufficiently secure thepositioning band 30 to thevessel wall 59 of theaorta 10 .

图9显示了主动脉10，定位带30通过缝合线70附接到其上，如参考图8A-8B所述。多个脱脂棉68显示在定位带70的内部，每个脱脂棉68通过本文所述的缝合步骤接触主动脉10的血管壁。Figure 9 shows theaorta 10 to which thepositioning band 30 is attached by sutures 70, as described with reference to Figures 8A-8B. A plurality ofpledgets 68 are shown inside positioning band 70 , each contacting the vessel wall ofaorta 10 through the suturing procedure described herein.

图10-11显示了用于在主动脉10内发生逆行A型主动脉夹层(RTAD)的情况下创建合适定位区的类似程序。图10显示了一个RTAD，在STJ 14附近存在一个主要入口撕裂80。主要入口撕裂80是主动脉壁中的撕裂，其产生与主动脉10的真内腔84分离的假内腔82。分割隔膜86是将假内腔82与真内腔84分开的薄弱的薄膜。如果不及时治疗，这可能是致命的。因此，定位带30可用于压缩主动脉10的外壁88，从而允许加强和愈合较薄、弱化的隔膜86。10-11 show a similar procedure for creating a suitable localization zone in the case of retrograde type A aortic dissection (RTAD) within theaorta 10 . Figure 10 shows an RTAD with aprimary entry tear 80 near theSTJ 14. Aprimary entry tear 80 is a tear in the aortic wall that creates afalse lumen 82 that is separated from thetrue lumen 84 of theaorta 10 . Separatingseptum 86 is a thin membrane that separatesfalse lumen 82 fromtrue lumen 84 . This can be fatal if left untreated. Accordingly, thepositioning band 30 can be used to compress theouter wall 88 of theaorta 10 , allowing the thinner, weakenedseptum 86 to strengthen and heal.

如图11所示，在升主动脉10的邻近STJ 14的近侧部分50处，通过在主要入口撕裂80的位置处附接定位带30可以再次创建近侧密封区。定位带30和支架移植物42可以如前所述附接和展开。由于定位带30，主入口撕裂80和分割隔膜86被自扩张血管内输送移植物42向上推靠定位带30，防止流入主要入口撕裂80。由于主要入口撕裂80的位置以及缺乏用于支架移植物的近侧密封区，传统的支架移植物将不能在近侧部分50处密封；放置在该位置的定位带30最适合治疗该疾病。如上所述，支架移植物42可以永久地固定到定位带30。As shown in FIG. 11 , at theproximal portion 50 of the ascendingaorta 10 adjacent to theSTJ 14 , a proximal seal can again be created by attaching apositioning band 30 at the location of theprimary entry tear 80 . Positioningband 30 and stent-graft 42 may be attached and deployed as previously described. Due to thepositioning band 30 , themain entry tear 80 and the dividingseptum 86 are pushed up against thepositioning band 30 from the dilatingendovascular delivery graft 42 , preventing flow into themain entry tear 80 . Due to the location of theprimary entry tear 80 and the lack of a proximal sealing area for the stent-graft, conventional stent-grafts will not seal at theproximal portion 50; positioningband 30 placed at this location is most suitable for treating this disease. As noted above,stent graft 42 may be permanently affixed to positioningstrap 30 .

图12示出了在TAVR过程中使用定位带的实施例。在主动脉不足的情况下，不能适当固定主动脉瓣时，可以使用本文所述的混合方法建立定位带30。定位带30再次放置在主动脉10的近侧部分50处。使用已知的TAVR程序部署具有长上部结构的瓣膜90。瓣膜90可向近侧延伸超过右冠状动脉22和左冠状动脉24。右冠状动脉22和左冠状动脉24通过瓣膜90框架的开孔设计灌注。利用上述教导，瓣膜框架的上部结构可以永久地固定到定位带30以防止瓣膜90移位或移动。定位带30可以在STJ 14处为主动脉10提供支撑，以防止由于瓣膜90的径向力而导致的扩张。这可以在主动脉不足的情况下改善瓣膜功能。这也可有助于防止由于患病主动脉根部和/或近侧升主动脉的持续扩张而导致AI再次发生。Figure 12 illustrates an embodiment of the use of positioning tape during TAVR. In cases of aortic insufficiency, where the aortic valve cannot be properly immobilized, positioningband 30 may be created using the hybrid approach described herein. Thepositioning band 30 is again placed at theproximal portion 50 of theaorta 10 . Thevalve 90 with its long superstructure is deployed using known TAVR procedures.Valve 90 may extend proximally beyond rightcoronary artery 22 and leftcoronary artery 24 . The rightcoronary artery 22 and the leftcoronary artery 24 are perfused through the ostium design of thevalve 90 frame. Using the above teachings, the upper structure of the valve frame can be permanently secured to thepositioning band 30 to prevent thevalve 90 from dislodging or moving. Positioningband 30 may provide support foraorta 10 atSTJ 14 to prevent dilation due to radial forces ofvalve 90 . This can improve valve function in cases of aortic insufficiency. This may also help prevent recurrence of AI due to continued dilation of the diseased aortic root and/or proximal ascending aorta.

瓣膜90显示为锥形，但可以使用其他形状以符合解剖结构。此外，可以执行定位带30的系紧以适应TAVR过程的直径比上述实施例中描述的更小。Valve 90 is shown as tapered, but other shapes may be used to conform to the anatomy. Furthermore, tightening of thepositioning strap 30 can be performed to accommodate smaller diameters for TAVR procedures than described in the above embodiments.

由于在自然升主动脉10的区域中没有足够的空间用于固定移植物、瓣膜等，因此定位带30提供了用于充分安装和固定的附加结构。图13显示了支架移植物42也固定到定位带30的实施例。在这个实施例中，瓣膜90和支架移植物42都附接到定位带30。使用本文阐述的一个或多个实施例中描述的方法，单个缝合线可以穿过支架移植物42和瓣膜90，以及血管壁和定位带30。一个或多个实施例可适用于将瓣膜置于具有扩张的STJ和/或患病升主动脉的解剖结构的情形中。在这种情况下，支架移植物没有近侧密封，通过瓣膜框架的上部结构灌注冠状动脉可继续灌注上行病变。支架移植物没有有效的近侧密封区，冠状动脉灌注可能导致大的I型内漏。除了稳定瓣膜之外，一个或多个实施例的带可以允许冠状动脉的持续灌注，同时在支架移植物的定位区中构建以排除一种或多种远侧病变。Since there is not enough room in the region of the native ascendingaorta 10 for securing grafts, valves, etc., thepositioning strap 30 provides additional structure for adequate mounting and securing. FIG. 13 shows an embodiment where astent graft 42 is also secured to thepositioning band 30 . In this embodiment, bothvalve 90 and stent-graft 42 are attached to positioningband 30 . Using the methods described in one or more embodiments set forth herein, a single suture may be threaded through stent-graft 42 andvalve 90 , as well as vessel wall andpositioning band 30 . One or more embodiments may be adapted to place the valve in anatomy with a dilated STJ and/or diseased ascending aorta. In this case, the stent-graft does not have a proximal seal, and perfusion of the coronary artery through the superstructure of the valve frame continues to perfuse the ascending lesion. Stent-grafts do not have an effective proximal sealing zone, and coronary perfusion can lead to large type I endoleaks. In addition to stabilizing the valve, the band of one or more embodiments can allow for sustained perfusion of the coronary arteries while building in the positioning region of the stent-graft to exclude one or more distal lesions.

尽管本文针对没有分支的支架移植物(例如，圆柱形或管状支架移植物)描述了实施例，但这些实施例的方面也可用于有分支的支架移植物，例如美国专利申请17/066,035中公开的，其全文以引用方式并入本文。本文所述的教导不旨在仅限于本文公开和图示的支架移植物，也不旨在仅限于图中所示的主动脉的特定位置。相反，本文提供的教导可以使用几种其他类型的支架移植物来实施，并且可以在人体解剖结构内的提供不充分的动脉组织用于定位和密封支架移植物的几个其他位置使用。Although embodiments are described herein with respect to unbranched stent-grafts (e.g., cylindrical or tubular stent-grafts), aspects of these embodiments can also be applied to branched stent-grafts, such as disclosed in U.S. Patent Application 17/066,035 , which is incorporated herein by reference in its entirety. The teachings described herein are not intended to be limited to the stent grafts disclosed and illustrated herein, nor are they intended to be limited to the particular location of the aorta shown in the drawings. Rather, the teachings provided herein can be practiced using several other types of stent-grafts, and can be used at several other locations within the human anatomy that do not provide adequate arterial tissue for positioning and sealing the stent-graft.

尽管上面描述了示例性实施例，但是并不意味着这些实施例描述了权利要求书所涵盖的所有可能的形式。说明书中使用的词语是描述性的词语而不是限制性的词语，并且应当理解的是，在不脱离本发明的精神和范围的情况下可以进行各种改变。如前所述，各种实施例的特征可以组合，以形成本发明的其他实施例，这些实施例可能没有明确地描述或示出。尽管可以将各种实施例描述为相对于一个或多个期望的特性提供优点或优于其他实施例或现有技术的实施方式，但是本领域普通技术人员认识到可以省去一个或多个特征或特性来实现期望的总体系统属性，这取决于具体的应用和实施方式。这些属性可以包括但不限于成本、强度、耐用性、生命周期成本、可销售性、外观、封装、尺寸、可维修性、重量、可制造性、易于组装等。因此，在任何实施例被描述为就一个或多个特性而言与其他实施例或现有技术实施方式相比不那么理想的情况下，这些实施例未超出本发明的范围，并且对于特定应用而言可能是理想的。While example embodiments are described above, it is not intended that these embodiments describe all possible forms encompassed by the claims. The words used in the specification are words of description rather than limitation, and it is understood that various changes may be made without departing from the spirit and scope of the invention. As previously stated, the features of various implementing embodiments can be combined to form other embodiments of the invention that may not be explicitly described or shown. Although various embodiments may be described as providing advantages with respect to one or more desirable characteristics or over other embodiments or prior art implementations, those of ordinary skill in the art recognize that one or more characteristics may be omitted or characteristics to achieve desired overall system properties, depending on the specific application and implementation. These attributes may include, but are not limited to, cost, strength, durability, life cycle cost, marketability, appearance, packaging, size, serviceability, weight, manufacturability, ease of assembly, and the like. Therefore, to the extent that any embodiments are described as being less than ideal with regard to one or more characteristics as compared to other embodiments or prior art implementations, such embodiments are not beyond the scope of the present invention, and for a particular application may be ideal.

Claims (20)

1. A method of providing support to a stent graft in a vessel of a patient, the method comprising:

wrapping a positioning band outside a portion of a blood vessel; then the

Securing the positioning band to maintain a selected diameter; then the

Delivering a stent graft in a radially contracted configuration intravascularly into a vessel; and then

Deploying the stent-graft to a radially-expanded configuration such that the stent-graft contacts the portion of the blood vessel surrounded by the positioning band and the positioning band supports the stent-graft from outside the blood vessel.

2. The method of claim 1, wherein:

the positioning band allows the stent-graft in a radially-expanded configuration to seal with a blood vessel.

3. The method of claim 1, further comprising:

anchoring the stent graft to the positioning band by an internal anchor.

4. The method of claim 3, further comprising:

delivering the internal anchor intravascularly through the vessel by an internal anchor introducer.

5. The method of claim 4, further comprising:

pressing at least one needle from the inner anchor guide through the stent graft and the positioning band, wherein the at least one needle carries a suture to enable a surgical technician to tie the suture from outside the vessel.

6. The method of claim 1, further comprising:

the selected diameter is selected using measurement indicia provided on the alignment tape.

7. The method of claim 1, wherein the wrapping of the localization zone is performed at a location of the blood vessel adjacent to a sinotubular junction of the blood vessel.

8. The method of claim 1, further comprising:

delivering a graft material intravascularly into a vessel, wherein the graft material is part of a valve or a second stent graft; and

securing the graft material and the stent graft to the positioning band.

9. The method of claim 8, wherein the step of securing the graft material and the stent graft to the positioning band comprises pressing an internal anchor through the stent material, through the stent graft, and through the positioning band.

10. A method of securing a stent graft within a vessel of a patient, the method comprising:

wrapping a positioning band outside a portion of a blood vessel;

securing the positioning band to maintain a selected diameter;

intravascularly delivering a stent graft to a portion of the vessel surrounded by a positioning band;

delivering an internal anchor intravascularly through the vessel and into a stent graft via an internal anchor introducer, the stent graft being inhibited from expanding the vessel due to the positioning band; and

sutures are pressed outwardly through the stent graft, vessel wall, and the positioning band.

11. The method of claim 10, further comprising:

the suture is tensioned to bring the pledget into contact with the vessel wall.

12. The method of claim 10, further comprising:

tying a surgical knot with the suture from outside the vessel to secure the stent graft to the positioning band.

13. The method of claim 10, wherein the step of pressing at least one needle comprises pressing the at least one needle through a graft material, wherein the graft material is a valve or a portion of a second stent graft that overlaps the stent graft.

14. The method of claim 10, wherein the step of pressing outwardly comprises pressing at least one needle from the inner anchor guide outwardly through the stent graft, through the vessel wall, and through the positioning band, wherein the at least one needle carries the suture, thereby enabling a surgical technician to tie the suture from outside the vessel.

15. A system for constructing a location zone for an endovascular procedure, the system comprising:

a positioning band configured to wrap around a portion of a blood vessel of a patient, wherein the positioning band has measurement indicia configured to assist a surgical technician in selecting a fixed diameter for support around the portion of the blood vessel;

a stent graft configured to be delivered intravascularly to the portion of the vessel that is wrapped by the positioning band; and

an inner guide configured to be delivered intravascularly to the portion of the vessel secured by the positioning band, wherein the inner guide carries a suture and is configured to, when manipulated by a surgical technician, press the suture through the stent graft, through a vessel wall and through the positioning band to secure the stent graft on the positioning band.

16. The system of claim 15, wherein the positioning band comprises at least one of surgical felt, polyethylene terephthalate (PET), expanded polytetrafluoroethylene (ePTFE), and Polyurethane (PU).

17. The system of claim 15, wherein the positioning band is shaped such that it forms a cone when wrapped around a blood vessel.

18. The system of claim 15, wherein the locating band comprises a mark on an inner surface thereof to indicate the start of the measurement mark, and a plurality of evenly spaced marks on an outer surface thereof.

19. The system of claim 15, wherein the inner guide includes at least one needle therein, the needle being movable within the inner guide, and wherein the at least one needle carries the suture and is configured to, when operated, pierce the stent graft, through a vessel wall, and through the positioning band.

20. The system of claim 19, further comprising pledgets coupled to the suture and configured to contact a wall of the blood vessel when the suture is pulled tight from outside the blood vessel by a surgical technician.

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